Rite-Dent Manufacturing Corp.
Hialeah, FL, US
Rite-Dent Manufacturing Corp. appears in FDA device records in Hialeah, FL. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Rite-Dent Manufacturing Corp. between 2001 and 2002. The busiest year on record is 2001, with 6. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 6 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K020050 | ENAMEL BONDING SYSTEM | KLE | Substantially Equivalent | |
| K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT | EBC | Substantially Equivalent | |
| K011453 | TOOTH SHADE RESIN MATERIAL | EBF | Substantially Equivalent | |
| K010255 | CAVITY VARNISH | LBH | Substantially Equivalent | |
| K010240 | POLYCARBOXYLATE (PCA) CEMENT | EMA | Substantially Equivalent | |
| K003427 | ZINC PHOSPHATE CEMENT | EMA | Substantially Equivalent | |
| K003426 | ALGINATE IMPRESSION MATERIAL | ELW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0128-06 | Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon Flavor, Pink Color b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color, Dustless d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color, Dustless g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient''s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. This product was cleared as a prescription device; however, it is not labeled as such. | At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain